Trial Radar IA | ||
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Lo studio clinico NCT07239661 per Carcinoma polmonare non a piccole cellule, Elettro-agopuntura, Inibitori di PD-1, ECOG PS 2 Points è in arruolamento. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui. | ||
Un studio corrisponde ai criteri del filtro
Vista a schede
Electroacupuncture Combined With PD-1 Inhibitor for ECOG2 Advanced NSCLC 120 Immunoterapia Basato su biomarcatori Randomizzato Sopravvivenza globale
I dettagli dello studio clinico sono disponibili principalmente in inglese. Tuttavia, Trial Radar IA può essere d'aiuto! Basta cliccare su 'Spiega lo studio' per visualizzare e discutere le informazioni sullo studio nella lingua selezionata.
La sperimentazione clinica NCT07239661 è uno studio interventistico per Carcinoma polmonare non a piccole cellule, Elettro-agopuntura, Inibitori di PD-1, ECOG PS 2 Points, attualmente in arruolamento. Avviato il 30 novembre 2025, prevede di arruolare 120 partecipanti. Sotto la guida di Kong Fanming, dovrebbe concludersi entro il 31 dicembre 2027. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 20 novembre 2025.
Sommario breve
The aim of this study was to systematically evaluate the clinical efficacy and safety of electroacupuncture (EA) combined with PD-1 inhibitors in patients with advanced non-small cell lung cancer (NSCLC) who have an ECOG performance status of 2 through a multicenter, randomized, sham-controlled clinical trial. The core scientific question addressed in this study was whether EA combined with standard immunotherapy cou...Mostra di più
Descrizione dettagliata
Based on the principles of evidence-based medicine, a randomized controlled clinical trial was conducted to provide high-quality evidence on the clinical efficacy and immunomodulatory effects of acupuncture combined with first-line immunotherapy in patients with advanced NSCLC with an ECOG PS2, thereby facilitating the promotion and application of "precision" traditional Chinese medicine (TCM) treatment. This project...Mostra di più
Titolo ufficiale
The Clinical Efficacy of Electroacupuncture Combined With PD-1 Inhibitor in the Treatment of ECOG2 Advanced Non-small Cell Lung Cancer
Patologie
Carcinoma polmonare non a piccole celluleElettro-agopunturaInibitori di PD-1ECOG PS 2 PointsAltri ID dello studio
- TYLL2025[K]016
Numero NCT
Data di inizio (effettiva)
2025-11-30
Ultimo aggiornamento pubblicato
2025-11-20
Data di completamento (stimata)
2027-12-31
Arruolamento (previsto)
120
Tipo di studio
Interventistico
FASE
N.D.
Stato
In arruolamento
Parole chiave
electroacupuncture
Immunotherapy
immune checkpoint inhibitor
Non-Small Cell Lung Cancer
ECOG PS 2 points
Immunotherapy
immune checkpoint inhibitor
Non-Small Cell Lung Cancer
ECOG PS 2 points
Scopo principale
Trattamento
Allocazione
Randomizzato
Modello di intervento
In parallelo
Mascheramento
Doppio
Bracci / Interventi
| Gruppo/Braccio di partecipanti | Intervento/Trattamento |
|---|---|
SperimentaleEA + ICIs group Bilateral Zusanli (ST36) and Sanyinjiao (SP6) acupoints were selected. After obtaining deqi sensation upon needle insertion, an electroacupuncture device was connected to each of the selected acupoints. A sparse-dense wave mode was chosen, with an intensity ranging from 0.5 to 2 mA, adjusted according to patient tolerance. The needles were retained for 20 minutes before removal. The electroacupuncture treatment was i...Mostra di più | Electroacupuncture (EA) In the electroacupuncture group, bilateral Zusanli (ST36) and Sanyinjiao (SP6) points were selected for needling. Upon achieving the "deqi" sensation, the electroacupuncture device was connected to the needles at both points. A dispersed-dense wave was applied with an intensity ranging from 0.5 to 2 mA, adjusted according to the patient's tolerance. The needles were retained for 20 minutes, after which they were remo...Mostra di più |
Comparatore simulatoSham EA + ICIs group Bilateral Zusanli (ST36) and Sanyinjiao (SP6) acupoints were selected. Electroacupuncture devices were connected to these acupoints. A sparse-dense wave mode was utilized, with an intensity ranging from 0.5 to 2 mA, and the needles were retained for 20 minutes before removal. In the sham electroacupuncture group, no manual manipulation was performed. The placement of electrodes and other treatment settings were ident...Mostra di più | Elettroagopuntura fittizia In the sham electroacupuncture group, bilateral Zusanli (ST36) and Sanyinjiao (SP6) points were selected for sham electroacupuncture intervention, which did not receive manual manipulation. The electrode placement and other treatment settings were identical to those in the electroacupuncture group, but no skin penetration, electrical output, or needle techniques were applied to induce the sensation of "deqi." No genu...Mostra di più |
Esito primario
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
progression-free survival | Defined as the interval from the time of enrollment to the first documentation of disease progression or death from any cause. | Defined as the time interval from the date of enrollment to the first documented occurrence of disease progression or death from any cause, whichever comes first. This outcome will be assessed up to 100 months. |
Assistente alla partecipazione
Criteri di eleggibilità
Età idonea
Adulto, Adulto anziano
Età minima
18 Years
Sessi idonei
Tutti
- Patients diagnosed with stage ⅢB-Ⅳ non-small cell lung cancer (NSCLC) confirmed by pathological or cytological examination;
- Patients with negative driver gene mutations, excluding those harboring EGFR mutations, ALK rearrangements, or other common driver gene alterations as determined by genetic testing or other molecular biological methods;
- An Eastern Cooperative Oncology Group (ECOG) performance status score of 2;
- A programmed death-ligand 1 (PD-L1) tumor proportion score (TPS) ≥ 1%;
- An expected survival time of more than 3 months, as assessed by the clinician based on the patient's overall condition, tumor progression, and response to treatment;
- Patients with good treatment compliance who provided written informed consent, confirming their understanding of and willingness to undergo treatment and follow-up according to the study protocol.
- Patients with a history or concurrent diagnosis of other malignant tumors within the past five years;
- Patients with severe organ impairment or serious comorbidities, such as cardiac dysfunction (New York Heart Association \[NYHA\] class Ⅲ-Ⅳ), hepatic or renal insufficiency, as determined by standard clinical examinations including liver and kidney function tests and electrocardiography;
- Patients with untreated central nervous system (CNS) metastases were excluded; eligible patients were required to have stable disease confirmed by imaging after receiving at least one systemic or surgical treatment;
- Patients with psychiatric disorders, including schizophrenia or bipolar disorder, particularly those requiring pharmacologic treatment;
- Patients with a history of multiple drug allergies, an allergic predisposition, or a history of severe allergic reactions such as anaphylactic shock or allergic rash;
- Subjects with active autoimmune or infectious diseases, including but not limited to chronic viral hepatitis, active pulmonary tuberculosis, or other infections or autoimmune disorders deemed by clinicians to potentially affect the study;
- Female patients who were pregnant or lactating.
Kong FanmingParte responsabile dello studio
Kong Fanming, Promotore-investigatore, Director of Oncology Department, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Contatti principali dello studio
Contatto: Fanming Kong, PhD, +86 22 27986525, [email protected]
1 Centri dello studio in 1 paesi
Tianjin Municipality
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, Tianjin Municipality, 300193, China
Fanming Kong, PhD, Contatto, +86 22 27986525, [email protected]
In arruolamento